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临床试验/NCT06935045
NCT06935045已完成不适用

Evaluating How Alcohol Impacts Physiological Responses and Perception During Heat Exposure

Lakehead University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年12月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Skin Temperature

研究概览

简要总结

Climate change has significantly increased the earth's average surface temperature and heat waves have been predicted to increase in frequency, intensity and duration. Extreme heat events have increased the susceptibility to heat-related illnesses, such as heat exhaustion, heat stroke or death. Heat health action plans have been designed to advertise cooling behaviours to mitigate physiological strain. Heat health action plans suggest avoiding alcohol consumption during extreme heat as it may increase dehydration and impair behavioural or physiological temperature regulation and thermal perception. Regardless of these messages, alcohol sales continue to remain high during the summer months year after year, and 1/5 of adults identify alcohol as a hydration strategy during extreme heat events. A recent scoping review investigating the effects of alcohol and heat has demonstrated that acute alcohol consumption does not negatively influence thermoregulation, hydration, or hormone markers of fluid balance in the heat compared to a control fluid (https://doi.org/10.1186/s12940-024-01113-y). Further, alcohol consumption may elicit sex- and age-specific alterations in physiological and perceptual responses, neither of which have been explored.

Therefore, this study aims to comprehensively evaluate how alcohol consumption systematically alters physiological responses and perceptions during conditions similar to those experienced indoors during extreme heat events in younger and older adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or Female above the age of 19
  • •Able to provide informed consent

排除标准

  • •History of cardiovascular disease, cancer, type 1 or 2 diabetes, chronic obstructive pulmonary disorder, cystic fibrosis, or alcohol addiction or dependence
  • •Been hospitalized due to COVID-19
  • •Pregnant/Breastfeeding
  • •Scoring an eight or above on the Alcohol Use Disorders Identification Test (AUDIT)

研究组 & 干预措施

Alcohol

Active Comparator

Consumption of alcohol beverages: females 0.75 ± 0.1 grams of ethanol/kilogram body mass; males 1.0 ± 0.1 grams of ethanol/kilogram body mass

干预措施: Alcohol (Ethanol) (Drug)

Placebo

Placebo Comparator

Placebo (non-alcoholic beverage)

干预措施: Placebo Beverage (Drug)

结局指标

主要结局

Skin Temperature

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

Mean skin (4 sites)

Core Temperature

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

measured rectally

Blood Pressure

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

ECG-gated blood pressure cuff

Heart Rate

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

3-lead electrocardiogram

Heart Rate Variability

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

Arrythmia presence

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

Whole-body Sweat Loss

时间窗: mass measured at baseline and end heat stress.

Difference in mass from baseline to end heat stress

Postural Sway via the Romberg Test

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

The total movement of the body around the center of mass with feet together

Skin Blood Flow

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

Urine Output

时间窗: Total urine output (e.g. volume) from baseline to immediately following 120 minutes of heat stress

ASHRAE seven-point thermal sensation scale

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

5-Point Thermal Comfort Scale

时间窗: measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).

Thermal comfort scale with 1- comfortable and 5 - very uncomfortable

次要结局

  • Subjective Blood Alcohol Concentration (visual analog scale 0.0 - 0.20)(measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).)
  • Blood Alcohol Concentration(measured at baseline (pre drink), and every 30 minutes following consumption (up to 120 minutes).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Ravanelli

Assistant Professor

Lakehead University

研究点 (2)

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